Principle of Vaccinology

Elham Ahmadnezhad MD. MPH. PhD Student of Epidemiology

Farshid fayyaz Jahani MD. MPH. Specialist in Infectious Disease & Tropical
Medicine
Tehran University of Medical Sciences
10/10/2011 Vaccinology. 1
Brief History of Lecturers
Elham & Farshid from Tehran, Iran are couple since 3 years ago (2008).
Farshid graduated from Medical School in Infectious disease and Tropical
medicine specialist and Elham now senior student in PhD of Epidemiology.
They have common interest in infectious disease epidemiology then
developed some lecturers such as this (Vaccinology).
Hope its useful for all target groups.
Our Email:
farshid.fayyazjahani@gmail.com
&
elhamahmadnezhad@gmail.com
10/10/2011 Vaccinology. 2
OUTLINE
Introduction & Definition
Vaccination policy option
Mass Vaccination
Surveillance System of Vaccination
Vaccine Development
Vaccine Evaluation
Vaccine Safety
Reporting Immunizations
Reliable Web sits
Vaccine Training Course
Review of National Immunization Coverage




10/10/2011 Vaccinology. 3
What is Vaccine
Dictionary (Dorland 30
th
edition 2008)
Attenuated or killed microorganisms or proteins derived from them, administered for
the prevention, treatment, or amelioration of infectious diseases
Wikipedia
A vaccine is a biological preparation that improves immunity to a particular disease. A
vaccine typically contains an agent that resembles a disease-causing microorganism,
and is often made from weakened or killed forms of the microbe. The agent stimulates
the body's immune system to recognize the agent as foreign, destroy it, and "remember"
it, so that the immune system can more easily recognize and destroy any of these
microorganisms that it later encounters.


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What is Vaccinology?

Vaccinology is the science of developing
vaccines to prevent diseases
10/10/2011 Vaccinology. 5
Vaccines-Historical Perspective
7th century- Indian Buddhists' drank snake venom to protect against snake bite.
10th century- Variolation to prevent smallpox in China and Turkey.
Early 1700s- Variolation introduced into England.
1760-70- The Jennerian era.
1875-1910- Dawn of Immunological Science.
1910-30- Early bacterial vaccines, toxins and toxoids.
1930-50- Early viral vaccines: yellow fever and Influenza.
1950-1970- The tissue culture revolution: poliomyelitis, measles, mumps and rubella.
1970-1990- Dawn of the molecular era: hepatitis B, Streptococcus pneumonia, Hemophilus influenza B.
Today- Glycoconjugate vaccines, rotavirus vaccine, human papilloma virus vaccine and herpes zoster
vaccine.
10/10/2011
Vaccinology. 6
Aims of Immunisation Programmes
To protect those at highest risk
(selective immunisation strategy)
or
To eradicate, eliminate or control disease
(mass immunisation strategy)

Currently, it is estimated that vaccination saves the lives of 3 million children a year

Eradication
Infection (pathogen) has been removed worldwide e.g. smallpox
Elimination
Disease has disappeared from one area but remains elsewhere e.g. polio, measles
Control
Disease no longer constitutes a significant public health problem e.g. neo-natal tetanus

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Vaccines Achievements1
With sanitation and nutrition, vaccines are hailed as one of the most
important public health achievements of the 20th century.
The history of vaccinology lends itself to discussion of its progress in terms
of periods or eras, in which new advances were made.
Once only targeted against serious childhood diseases, vaccinology has
become a tool for preventing infectious diseases or their complications
and outcomes in all age groups.
This has seen the number of vaccine-preventable diseases rising to around
26.

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Vaccines Achievements2
At the end of the 20th century the US Centers for Disease
Control and Prevention (CDC) cited vaccination as the
number one public health achievement of that century


The elimination in 1977 of smallpox as a human disease
must rank as one of the major achievements of modern
medicine
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The Ideal Vaccine
Immunogenic
Long lasting immunity
Safe
Stable in field conditions
Combined
Single dose
Affordable (and accessible) to all

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Categorization of Current Vaccines

Live attenuated: Viruses (oral polio, measles, mumps, rubella,
yellow fever), Bacteria (BCG, cholera)- Long lasting immunity, very
fragile (cold chain), mutation to pathogenicity
Killed Vaccines: Viruses (hep. A, Salk polio) Bacteria (pertussis,
cholera)-intermediate immunity, several doses may be required
Sub-unit vaccines incl: Toxoids: (tetanus, hep b.,occellular vaccines),
Conjugate polysacaride vaccines linked with suitable carrier
proteins (Hib). Also single or polyvalent vaccines.

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Viral Vaccines
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Bacterial Vaccines
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Target Fungal Vaccines
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Target Parasitic Disease
Malaria
Trypanosomiasis
Leishmaniasis
Toxoplasmosis
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Selective Vaccination
Vaccine given specifically to those at increased risk of disease:
High risk groups
e.g. Pneumococcal vaccine
Occupational risk
e.g. Hepatitis B, influenza
Travellers
e.g. Yellow fever, rabies, meningitis
Outbreak control
e.g. Hepatitis A. vaccine, measles
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Pipelines for Developing Countries
Much needed vaccines for the developing world
Malaria
Tuberculosis
HIV
Hookworm
Dengue
Enterotoxigenic Escherichia coli
Shigella
10/10/2011 Vaccinology. 17
More Possibilities
Therapeutic vaccines: Identification of specific tumor
antigens provide immune targets for which immunogenic
vaccines may conceivably be designed. Examples:
Leukemia
Breast cancer
Melanoma
Prostate cancer
Colon cancer

Vaccines against autoimmune diseases
10/10/2011 Vaccinology. 18
Similarities between Vaccines and
other Drug
Vaccines are also medicines
Potential for adverse effects
Multiple ingredients
Potential for interaction with disease and other
medicines
Also need to comply with standards of safety, efficacy
and quality

10/10/2011 Vaccinology. 19
Vaccination Policy Options
10/10/2011 Vaccinology. 20
Eradication Activities
New Vaccine
Introduction
Outbreak vs. routine
control of epidemic
diseases
?
Newer Vaccine
Research and
Development
Role of disease burden studies in the development and
introduction of new and underutilized vaccines
Disease-Burden Studies
Disease Epidemiology
Geographical distribution
Age groups
Seasonality, risk factors
Vaccine
Design
Clinical Evaluation
Study sites
Vaccination schedules
& Strategies
Vaccine Utilization
Target groups
Impact
Cost-effectiveness
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Mass Vaccination
Objective: Make hosts resistant to infection without
having to experience disease

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Impact of Mass Vaccination Programmes
Reduce size of susceptible population
Reduce number of cases
Reduce risk of infection in population
Reduce contact of susceptible to cases
Lengthening of epidemic cycle -> honeymoon
phase
Increase in mean age of infection

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No Mass Vaccination
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Each host in contact with infected host becomes infected (with a certain
probability)
Mass Vaccination
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Outbreak attenuated (or averted) by lack
of susceptible hosts



Impact of Mass Immunisation Programme

Annual measles notifications & vaccine coverage
Poland 1960-2000
0.0
100.0
200.0
300.0
400.0
500.0
600.0
Year 1964 1969 1974 1979 1984 1989 1994 1999
Year
C
a
s
e
s
/
1
0
0

0
0
0
0
10
20
30
40
50
60
70
80
90
100
I
m
m
u
n
i
s
a
t
i
o
n

c
o
v
e
r
a
g
e

(
%
)
Vaccination at 12-15 mo Vaccination at 6 years Cases /100 000
10/10/2011 Vaccinology. 26
Surveillance of Vaccine Preventable Disease
Vaccine uptake
Vaccine effectiveness
Serological surveillance
Adverse events
Knowledge and attitudes
Vaccine uptake
Disease incidence

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Objectives of Surveillance
Vaccine Preventable Diseases
Pre-implementation
Estimate burden
Decide vaccination strategy
Post implementation
Monitor impact and effectiveness
Nearing elimination
Identify pockets of susceptible
Certification process

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Disease Incidence
Main sources of data
Statutory notification
Laboratory reporting
Death registrations
Other sources
Hospital episodes
Sentinel GP reporting
Paediatric surveillance

10/10/2011 Vaccinology. 29
Measles Case Definitions
Suspect case
Rash and fever

Probable case
Rash, fever, and either: cough, coryza or conjunctivitis

Laboratory confirmed
Saliva/serum IgM positive

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Predictive Value of Notified Measles
Effect of Change in Incidence
10/10/2011 Vaccinology. 31
1
10
100
1000
10000
100000
1000000
Pre-vaccine Low coverage High coverage Near elimination
N
u
m
b
e
r

o
f

c
a
s
e
s
0%
20%
40%
60%
80%
100%
P
V
+
Non-measles Genuine measles
Surveillance of Vaccine Coverage
Vaccine distributed
Vaccine administered
Sampling population assessment e.g. Cluster

Total population assessment (administrative)

Number of doses of vaccine given/used
Total (target-)population

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Use of Administrative Coverage Data
Usually total population
Monitor trends over time
Look for pockets of poor coverage
Compare with disease epidemiology
Estimate vaccine effectiveness

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Steps on Vaccine Development1
Recognize the disease as a distinct entity
Identify etiologic agent
Grow agent in laboratory
Establish in animal model for disease
Identify an immunologic correlate for immunity to the disease- usually
serum antibody
Inactivate or attenuate the agent in the laboratory- or choose antigens
Prepare candidate vaccine following GOOD manufacturing Procedures
Evaluate candidate vaccine(s) for ability to protect animals
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Steps on Vaccine Development2
Prepare protocol(s) for human studies
Apply to MCC for investigational New drug (IND)
approval
Phase I human trials- Safety and immugenicity,
dose response
Phase II trials- Safety and immugenicity
Phase III trials- Efficacy
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Steps on Vaccine Development3
Submit Product Licensure Application MCC approval
Advisory Committees review and make recommendations
Marketing Post- Licensure Surveillance for safety and effectiveness
(Phase IV)
Long and Complicated process
Usually takes 10-15 years
Many vaccine candidates fail for every success
Costs: $ 100- $ 700 million per successful vaccine
10/10/2011 Vaccinology. 36
Vaccine Evaluation
Pre-licensing
Randomised, Blinded,
Controlled Clinical Trials

Vaccine efficacy:
Protective Effect under
Idealised Conditions

RCT: controlled experiments,
simple interpretation

Post-licensing
Observational Studies

Vaccine effectiveness:
Protective Effect under
Ordinary Conditions of a
public health programme

prone to bias, more complex
interpretation

10/10/2011 Vaccinology. 37

Efficacy, Effectiveness, Impact and Herd Immunity

Efficacy is the direct protection to a vaccinated individual as estimated from clinical trial

Effectiveness is an estimate of the direct protection in a field study post licensure.

Herd Immunity is an indirect effect of vaccination due to reduced disease transmission.

Impact is the population level effect of a vaccination programme. This will depend on
many factors such as vaccine coverage, herd immunity and effectiveness.
10/10/2011 Vaccinology. 38


Basic Calculation of VE

% reduction in attack rate of disease in vaccinated (ARV)
compared to unvaccinated (ARU) individuals
VE (%) = (ARU-ARV) X 100
ARU
Where

and


Consequently, VE = 1-RR (preventive fraction)
10/10/2011 Vaccinology. 39

ARU
ARU
=1

ARV
ARU
= RR
0,9 0,2

0,9
VE

=
= 78%
Vaccinated
I
V
= 2/10 = 0,2
I
U
= 9/10 = 0,9
Unvaccinated


Basic Calculation of VE

10/10/2011 Vaccinology. 40
Methods to Assess VE
Pre-licensure:
Randomised control trial (RCT)

Post-licensure:
Observational/Field investigation
Screening method
Cohort study
Household contact study
Case-control study
10/10/2011 Vaccinology. 41
Observational study: Screening Method

Used with Routine Surveillance Data
Take population vaccine coverage (PPV)
Compare with coverage in cases (PCV)


VE = 1 - PCV x (1-PPV)
(1-PCV) x PPV

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Observational study: Screening Method
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R e l a t i o n s h i p b e t w e e n V E , P P V a n d P C V
0
0 . 2
0 . 4
0 . 6
0 . 8
1
0 . 5 0 . 6 0 . 7 0 . 8 0 . 9 1
P r o p o r t i o n o f p o p u l a t i o n v a c c i n a t e d
P
r
o
p
o
r
t
i
o
n

o
f

c
a
s
e
s


v
a
c
c
i
n
a
t
e
d

V E = 6 0 %
V E = 8 0 %
V E = 9 0 %
V E = 9 5 %
Potential Pitfalls....

Case definition;

Vaccine history;

Case ascertainment;

Comparability of vaccinated/unvaccinated groups.
10/10/2011 Vaccinology. 44
Methodological Issues: Case Definition1
Lower specificity: Case definition based only on clinical
criteria may result in false-positive diagnoses

ARV > ARU


VE (%) = (ARU-ARV) X 100
ARU

artificial reduction in VE
10/10/2011 Vaccinology. 45
Methodological Issues: Case Definition2
Changes in MUMPS vaccine effectiveness
Case definition
Diagnosis by school nurse
ARV 18% (12/67) 89
ARU 28% (77/272) 25% (68/272)
VE 37% 52%




Kim Farley et al 1985 AJE
10/10/2011 Vaccinology. 46
Changes in MUMPS vaccine effectiveness
Case definition
Diagnosis by school nurse Parotitis > 2 days
ARV 18% (12/67) 12% (8/67)
ARU 28% (77/272) 25% (68/272)
VE 37% 52%




Kim Farley et al 1985 AJE
10/10/2011 Vaccinology. 47
Methodological Issues: Case Definition2
Methodological issues: Vaccine History Ascertainment
Avoid misclassification of vaccination status
Equal effort to confirm vaccination status
amongst cases and non-cases
Vaccination histories should be documented using GP, clinic,
hand-held or computer records
Persons with missing vaccination records should be excluded
10/10/2011 Vaccinology. 48
Vaccine effectiveness: Post licensure monitoring of VE
Post-licensure: maintenance of VE
Problems in vaccine delivery
Cold chain failure, schedule violation, n of doses, vaccine strain substitution
Epidemiological factors
Pathogen changes
Methodological bias
Selection bias, confounding, chance effects
Low protective efficacy
Bad batch, different target population, alternative patterns of use, vaccine
strain used
10/10/2011 Vaccinology. 49
Summary of VE
Multiple sources of data are valuable to
evaluate vaccine programmes
Source of data and case definitions change
with stage of vaccination programme
Monitoring VE is integral
VE can be carefully estimated from routine
data
10/10/2011 Vaccinology. 50
Lets GO An Example
10/10/2011 Vaccinology. 51
A Randomized, Controlled Experiment
400,000 elementary school students
participated in the experiment.
200,000 chosen at random from 400.000 in
the treatment group got the vaccine.
The remaining 200,000 in the control group
did not get the vaccine.
10/10/2011 Vaccinology. 52
A Randomized, Controlled Double-Blind Experiment
The 200,000 children in the control got a fake
vaccination called a placebo.
The children and their parents were not told if
they got the real vaccine or not.
Even the doctors and nurses didnt know; only
the statisticians knew

10/10/2011 Vaccinology. 53
Experimental Results
Looks promising but is it significant?
10/10/2011 Vaccinology. 54
Size Rate
Treatment 200,000 28
Control 200,000 71
Total 400,000 99
Analysis: The Devils Advocate
Lets play the devils advocate. Lets assume
the vaccine has no effect.
Then the 99 cases of polio were split into the
two groups purely at random.
Is it very likely only 25 fall in the treatment
group?

10/10/2011 Vaccinology. 55
A Probability Model
Put 400,000 balls in an urn with 99 black and the rest white.
Draw 200,000 (for the treatment group) and count the
number of black balls.
What is the chance of a split as extreme or more extreme
than 28 in the treatment group and 71 in the control group.
About one in a billion

10/10/2011 Vaccinology. 56
Calculating Probabilities
A statistician relies on the theory of probability to
calculate probabilities.
The number of black balls X in the treatment group
follows the hypergeometric distribution.



10/10/2011 Vaccinology. 57
99 399901
200000
400000
200000 x x
|
\

|
.
|

|
\

|
.
|
|
\

|
.
|
Conclusion: Get vaccinated!
We must reject the hypothesis that the treatment has no
effect; otherwise we must believe we are incredibly
unlucky.
We can therefore recommend mass vaccination.
We also note a vaccination does not prevent polio. Your
best protection is to get vaccinated and encourage
everyone to be vaccinated.
10/10/2011 Vaccinology. 58
Vaccine Safety
10/10/2011 Vaccinology. 59
Todays Agenda
The Good
The benefits of vaccination
Ongoing safety monitoring
The Bad
Vaccines rocky past
Acceptable risk?
And the Ugly
Wealth of misinformation
Vaccine refusal
10/10/2011 Vaccinology. 60
Vaccines Work
JAMA 2007 298(18)2156-2163
MMWR August 22, 2008 903-913
10/10/2011 Vaccinology. 61
Pre-licensure Safety Monitoring1
10/10/2011 Vaccinology. 62
Pre-licensure Safety Monitoring2
Vaccine Adverse Event Reporting System (VAERS)
Limitations
Vaccine Safety Datalink (VSD)
Established in 1990 by CDC and 8 HMOs
Database on 8.8 million lives
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Safety Monitoring -
Who looks at all that data?
Institute of Medicine (IOM)
Part of the National Academy of Science
Non-profit, non-governmental organization, volunteer
Provide the CDC, NIH and congress on data interpretation on matters of
bio-medical science
IOM Vaccine Safety Reports The Gold Standard in vaccine safety
analysis
MMR and Autism (2001)
Thimerosal and Neurodevelopmental Disorders (2001)
Multiple Immunizations and Immune Dysfunction (2002)
HepB Vaccine and Demyelinating Neurological Disorders (2002)
SV40 Contamination of Polio Vaccine and Cancer (2002)
Influenza vaccines and Neurological Complications (2003)
Vaccines and Autism (2004)
10/10/2011 Vaccinology. 64
The Bad
The Cutter IPV incident (1955)
Vaccine associated paralytic polio
Swine flu vaccine and GBS (1976-7)
10/10/2011 Vaccinology. 65
The Cutter Incident
1950s Jonas Salk pioneering work with IPV
5 companies stepped forward to manufacture IPV
after licensure
Cutter (the smallest) made a bad batch
100,000 children injected with live virus
70,000 got mild polio
200 were permanently paralyzed
10 died
10/10/2011 Vaccinology. 66
Vaccine-Associated Paralytic Polio
(VAPP)
OPV is a live attenuated virus
1 out of 2.4 million doses VAPP
1997 a IPV/OPV schedule
2000 an all IPV schedule recommended
10/10/2011 Vaccinology. 67
Swine Flu vaccine of 1976-1977
Increased risk of Guillain-Barr syndrome (GBS)
Risk period was 6-8 weeks after vaccine and most
>25 yrs of age
Incident of 1 per 100,000
Above the background rate of 0.87 per million
persons in a 6 week period
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Acceptable Risk?
Local side effects
Swelling, redness
Systemic side effects
Fever, pain, allergic reaction
MMR and Thrombocytopenia
MMR(V) and febrile seizures
Adolescent vaccines and syncope
Guillain-Barr and MCV4
10/10/2011 Vaccinology. 69
MMR & Thrombocytopenia
Yes
1 in 40,000 at 12-23 months
Less common than after natural disease

Journal of Autoimmunity 2001 16: 309-18




10/10/2011 Vaccinology. 70
MMR(V) & Febrile Seizures
10% develop fever after 1st MMR dose
Febrile Seizure Risk
4 cases / 10,000 doses MMR + V
9 cases / 10,000 doses MMRV


MMWR 2008 57: 258-60
10/10/2011 Vaccinology. 71
Syncope and Adolescent Vaccines
MMWR May 2, 2008 / 57(17);457-460
10/10/2011 Vaccinology. 72
Guillain-Barr Syndrome and MCV4
MCV4 (Menactra) licensed in Jan 2005
Sept 2005 alert by FDA/CDC:
2.5 million doses
5 cases of GBS in month following vaccine (VAERS data)

10/10/2011 Vaccinology. 73
and the Ugly
Wealth of misinformation
MMR and Autism
Mercury poisoning
Vaccines overwhelming the immune system
Vaccine refusal
10/10/2011 Vaccinology. 74
Reporting Immunization Requirements


Documenting administration of vaccine
Documenting record of immunization
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Reporting immunization requirements: Documenting
administration of vaccine Content

Name and address of vaccine
Medicare number
Date of birth and gender
Date of administration
Name and lot number of vaccine
Name of immunizer
Other data as required
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76
Reporting immunization requirements: Documenting
administration of vaccine Content-Lot Number
3 lot numbers on packaging:
On antigen carton
On adjuvant carton
On shoe box

Document lot number
on shoe box.
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77
Immunization Practice Standards
Vaccine management
Informed consent
Administration of vaccine
Documentation
Anaphylaxis management
Reporting of adverse events
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Immunization practice standards: Vaccine
management-Storage and handling of vaccine

Cold chain system
Control procedure/mechanism/equipment
Vaccine fridge
Dialer and data logger
Vaccine coolers
Cold and warm marks or minimum-maximum
thermometers
Cold chain breach
79
Immunization practice standards Informed
consent
Parental consent required for individuals
less than 16 years old
Risk vs. benefits (of receiving vaccine or not)
General info about vaccine and potential side effects
Ensure info is well understood
Allow opportunities for questions
Assess health with screening questions
Document informed consent
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Immunization practice standards
Informed consent
Screening Questions (Examples)
Is unwell today?
Has history of severe life-threatening allergy to
Eggs
Previous dose of the vaccine; or
Any of its components
Past history of Guillain Barre Syndrome
Has disease or treatment lowering immunity
Has severe bleeding disorder
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Immunization practice standards
Administration of vaccine
Intramuscular injection
IM in vastus lateralis
(Birth to 18 months)

IM in deltoid
(18 mths and over)

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Source : http://www.health.gov.nl.ca/health/publications/immunization/S4/
Immunization practice standards
Administration of vaccine
Post-vaccination
Check
For bruising, redness, swelling
Client for any adverse event
Instruct client
To wait 15 minutes
Of possible side effects and what to do
To call if adverse event in next 4 weeks
Need for a second dose
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Immunization practice standards Documentation
Consent form: Pandemic H1N1 Influenza
Immunization
Client immunization record
Adverse event following immunization
CSDS as directed
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Immunization practice standards Anaphylaxis
management
Assess and manage ABCs
Call for help
Administer epinephrine
Call 115
Repeat dose as needed
Document and share clinical info
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86
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Immunization practice standards
Reporting AEFI -
Current surveillance process
AEFI form to be completed by PH or physician
Form submitted to RMOH
PH enters data in CSDS and sends form to CDC
Unit
CDC Unit faxes form to PHAC
Refer to NB Immmunization Handbook
Immunizers: inform
clients to call PH if
severe or unusual
reactions in the 4
weeks following
vaccination.
87
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Immunization practice standards Reporting AEFI -
Enhanced severe AEFI surveillance
AEFI form to be completed by physician
May be completed by PH when reported to PH first
Form submitted to RMOH
PH enters data entered in CSDS and sends form to CDC Unit
Refer to GNB website for reporting process, case definition and form
http://www.gnb.ca/0053/h1n1/audience_professionals-e.asp
88
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Immunization practice standards
Reporting AEFI -
Enhanced severe AEFI surveillance
Weekly active AEFI reporting

Internal medicine specialist and neurologists will submit weekly count of
cases meeting case definition of 8 conditions along with DOB and name
to CDC Unit via special email address.
CDC Unit will send the information to MOH.
Timely data to be used be regional PH to ensure complete reporting of
AEFI.
Used injection material
Handling
Disposal

Sharp containers
Where to place
When to replace
How to dispose of

Needle stick injury refer to RHA policy
Use of personal protective equipment and infection control measures
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Immunization practice standards
Occupational health issues
Reliable web sites
10/10/2011 Vaccinology. 90
CDC Vaccines and Immunization
Contact Information
Telephone 800.CDC.INFO

Email nipinfo@cdc.gov

Website
www.cdc.gov/vaccines
Vaccine Safety
www.cdc.gov/od/science/iso

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Promote Epidemiology Training & Research

WHO Advanced Training Course on Immunology, Vaccinology,
and Biotechnology Applied to Infectious Diseases

Liaison with epidemiology training programmers
INCLEN, FETP, EPIET

WHO Collaborating Centers

10/10/2011 Vaccinology. 93
References
Geoffrey A. Weinberg and Peter G. Szilagyi. Vaccine Epidemiology: Efficacy, Effectiveness ,and the Translational Research Roadmap. The
Journal of Infectious Diseases 2010; 201 (11): 1607 -1610
European Program for Intervention Epidemiology Training. Principle of Vaccinology. 2008
EPI coverage survey, WHO. Available at: http://www.who.int/immunization_monitoring/routine/EPI_coverage_survey.pdf. Access date:
10.10.2011
Geert Leroux-Roels, Paolo Bonanni, Terapong Tantawichien,Fred Zepp. Understanding Modern Vaccines: Perspectives in Vaccinology
Vaccine development. Volume1/ Issue1/ 115-150
Thomas D. Szucs. Health economic research on vaccinations and immunization practicesan intro uctory primer. Vaccine 23 (2005):
20952103
NB Immunization Handbook, sections IV-III, IV-IV
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